A Randomized, Double-Blind, Placebo Controlled, Phase Ib Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple-Dose Escalation HS-10383 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Evaluation
研究概览
简要总结
This study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 in healthy subjects using a randomized, double blind, placebo controlled, single center study design.
详细描述
HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1b study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 administered orally to healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged from 18 to 45 years
- •Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent;
- •Male weight ≥ 50kg, female weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18~26 (including the critical value);
排除标准
- •The following medical histories, such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system and tumor, etc., were screened. evaluated as unsuitable to participate in this study;
- •Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
- •Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
- •Use of any drugs, including prescription drugs, over-the-counter drugs or herbal preparations, cannot be avoided or expected to start 2 weeks (or 5 half-lives) before screening and throughout the study period;
- •Any findings of electrocardiogram outside from normal, such as the QT interval (QTcF) corrected by the Fridericia formula, the absolute value of QTcF for males is >450 ms, and the absolute value of QTcF for females is >470 ms;
- •Any findings of blood pressure or pulse in resting state outside from normal a: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm;
研究组 & 干预措施
HS-10383 (Multiple doses)
Escalating doses of HS-10383 administered orally once daily for a week in healthy participants.
干预措施: HS-10383 (Drug)
HS-10383 Placebo (Multiple doses)
Escalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants.
干预措施: HS-10383 Placebo (Drug)
结局指标
主要结局
Safety and Tolerability Evaluation
时间窗: up to 15 days
Number of participants experiencing AE with abnormal vital sign
Number and severity of treatment emergent adverse events
时间窗: up to 15 days
Safety and Tolerability Evaluation
Number of participants experiencing AE with abnormal laboratory values
时间窗: up to 15 days
Safety and Tolerability Evaluation
Number of participants experiencing AE with abnormal Electrocardiograph
时间窗: up to 15 days
Safety and Tolerability Evaluation
次要结局
- Area under the curve (AUC)(up to 192 hours after the last dose)
- Maximum plasma concentration (Cmax)(up to 192 hours after the last dose)
- Time of Maximum Concentration (Tmax)(up to 192 hours after the last dose)